ANZCTR search results

We will conduct a program of work that includes a randomised controlled trial (RCT) of the psychoeducation counselling intervention (Phase 1), an economic evaluation (Phase 2) and a qualitative investigation (Phase 3). Phase 1 will determine the efficacy of a mid-wife-led psycho-education counseling intervention to address women's childbirth fear and enhance confidence. The intervention aims to assist women to identify and work through distressing and/or fearful elements of childbirth, review their expectations and/or previous birth experiences, and understand their birth choices. Phase 2 intends to assess the cost effectiveness of the intervention relative to maternal and neonatal outcomes. Phase 3 aims to identify any differences in the narratives of women's antenatal experiences in the control and intervention group. A random sample of women will be interviewed to explore their childbirth fears and anxieties and how these influences decisions about mode of birth. Participants will also be asked to evaluate their experience of the intervention. Design: We will conduct a randomized controlled trial (RCT) of a psychoeducation intervention (Phase1) , an economic evaluation (Phase 2) and a qualitative investigation (Phase 3). Hypotheses: Relative to women allocated to the control group, women receiving the intervention will (1) report lower levels of childbirth fear, anxiety and depression at term; (2) have high confidence and self efficacy in their ability to give birth ; and (3) demonstrate superior outcomes on mental health indices and adjustment to motherhood in the postpartum period. Outcome Measures: The primary outcome measure will be a reduction in childbirth fear. Secondary outcomes include improved confidence to give birth, childbirth self-efficacy, social support, decisional conflict, obstetric and mental health outcomes, maternal and neonatal outcomes, quality of life and use of health services. Setting: Antenatal clinics of Gold Coast, Logan and Redland Hospitals. Sample and Sample Size: Pregnant women in their 2nd trimester (12-22 weeks) will be invited to participate. A sample size of 150 participants in each group is required (recruitment approx n=1200 women for assessment of birth fear prior to randomization). Around 40 women (20 from each group) will be randomly selected and invited to participate in an in-depth interview about their experiences (Phase 3). Inclusion Criteria: All women attending the antenatal clinics of participating sites in the second trimester of pregnancy will be invited to participate. They must be able to communicate sufficiently to discuss their concerns about birth and be 16 years or older. Those participants reporting high fear of childbirth on the W-DEQ will be randomised. Exclusion Criteria: If after recruitment women come to expect a perinatal death (e.g. congenital abnormality incompatible) or stillbirth they will be given an opportunity to withdraw from the study. If they opt to continue they will be offered counselling support and receive newsletters if they request. Follow up questionnaires containing parenting questions will not be administered.

This research will explore the effect of arm dominance on vein diameter and whether vein occupation ratio is predictive of DVT. This will inform current practice and assist in the development of an evidence based protocol for vein assessment and choice to enhance patient safety.

The study will be assessing whether rectal side effects from radiation treatment can be reduced, by using a spacing agent between the rectum and prostate gland. The agent is a gel, which is injected in the space between the prostate gland and rectum, in order to increase separation between these two structures. The idea is that the rectal radiation dose and hence side effects, will be reduced by the increased separation.

Ablation techniques are used to directly destroy tumours within an organ. The location of the tumours is predetermined with imaging. With image guidance, needles are inserted through the skin (percutaneously) into the tumour and an energy field (heat, cold, microwaves, ultrasound etc) is used to destroy the tumour cells. Irreversible Electroporation (IRE) is a new ablation technology that has been shown to have advantages over other more established technologies. It uses high voltage direct electrical current to open the cell membranes and destroy tumours but spares surrounding tissues and vital structures such as nerves and blood vessels. The Study: Current surgical and ablative treatment options for prostate cancer have a relatively high incidence of side effects, mainly incontinence and erectile dysfunction, that diminish the quality of life of prostate cancer sufferers and impact on patients’ decision to undergo early, potentially curative treatments. These side effects are due to procedure related damage of the blood vessels, ureter and/or neurovascular bundle. New treatments that limit damage to these structures have the potential to improve patient outcomes. Ablation with Irreversible Electroporation (IRE) has been shown to be effective in destroying tumour cells and to have the advantage of sparing surrounding tissue and vital structures such as blood vessels and neurones. It is therefore postulated that this advantage may help reduce or avoid these side effects. The purpose of this study is to evaluate the safety, precision and cost of minimally invasive, percutaneous, image guided IRE for the ablation of prostate cancer. Who is it for? This study is eligible for up to six patients diagnosed with confirmed prostate cancer with no evidence of lymph node or distant metastases, categorised as low risk (as defined by the American Urological Association Guideline for Management of Clinically Localized Prostate Cancer: 2007 Update, as a clinical score of T1-2a, a Gleason score of 7 (3+4 only) or less, and a PSA less than or equal to 10 ng/ml) and scheduled for a radical prostatectomy by the treating urologist will have the IRE procedure 14-30 days before the prostatectomy. Participants will have preprocedure urological and prostate cancer assessments (Expanded Prostate Cancer Index Composite (EPIC) and International Prostate Symptom Score (IPSS). A specified ablation zone will be predetermined using the same preplanning used for conventional brachytherapy treatment. The procedure for planning and performing brachytherapy is well established in the Radiation Oncology Department at The Alfred. It involves determining the volume (size and shape) of the prostate. Trial Details In this study, you will undergo Irreversible Electroporation (IRE) procedure which involves two fine needle electrodes being placed percutaneously into the prostate in the same way as a biopsy is performed. An electric current is passed between the needle electrodes, which causes the pores of the cell membranes to open, thereby killing the cells. The procedure will take about an hour and a half, and will be performed by either the study urologist or study radiation oncologist with assistance with the technology by the study radiologists. You will then be followed up at 1, 2 and 4 weeks, where testing for any adverse events and urological and prostate assessments will be performed. When the prostate is removed it will be examined histologically (microscopically) to ascertain the effectiveness of ablation by the Anatomical Pathology Department at The Alfred. We will be able to know if complete ablation of the specified area was achieved.

This study will evaluate the effect of combining standard chemotherapy with the drug, BNC105P, for the treatment of partially platinum sensitive ovarian cancer. Who is it for? You may be eligible to join this study if you are a female aged 18years or above and have a diagnosis of epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer, for which you have undergone first or second line platinum based chemotherapy. Your cancer should not have progressed for at least 4 months following this chemotherapy. Trial details There are two parts to this study. Each participant will be involved in one part only. In part 1 of the study, participants will undergo chemotherapy with carboplatin, gemcitabine, and BNC105P for up to 6 cycles (each cycle is 21 days). Subsequent patients will receive escalating doses of these drugs in order to determine the maximum tolerated dose. Participants will then undergo a further 6 cycles of maintenance therapy with BNC105P only. Participants enrolled in part 2 of this study will be randomly (by chance) allocated to one of two groups. Both groups will undergo standard chemotherapy with Carboplatin and Gemcitabine for 6 cycles (each cycle is 21 days). However, one group will also receive the maximum tolerated dose (determined in part 1 of the study) of BNC105P during these cycles. Both groups will then undergo a maximum of 6 cycles of maintenance therapy with BNC105P. Participants in both parts of the study will be assessed at regular intervals in order to evaluate the safety of treatment, response rate, and quality of life.

The aim of this study is to evaluate the use of a self-guided internet treatment program for OCD. It is hypothesized that: 1. The treatment group will show significant improvement on primary measures of OCD symptoms relative to baseline and 2. The treatment will be deemed as acceptable by participants

The purpose of this study is to assess the impact of Gamma3 intramedullary nails versus sliding hip screws on health-related quality of life as measured by the EuroQuol-5D at 52 weeks in individuals with trochanteric fractures. Secondary outcomes include revision surgery rates, fracture healing rates, fracture related adverse events, and health-related quality of life, including the Parker mobility score and Harris Hip Score.

Persistent asthma is a major problem yet none of the current therapies do more than control the condition. The long-term solution is to prevent asthma from progressing to the persistent form. The major risk factors are: family history, early allergy and recurrent severe lower respiratory infections (sLRI) in the early life. We will conduct a randomized clinical trial to prevent sLRI using a novel bacterial-derived immunostimulant (OM-85) in infants at high risk of developing asthma. OM-85 works by priming the immune system so that body can respond quickly to infections. This will help reduce damage to the lungs during sLRI's and may prevent asthma from developing.

CanPrevent: This study investigates the feasibility and short-term effectiveness of a lifestyle intervention for first degree relatives of colorectal cancer survivors. Who is it for? First degree relatives (parents, siblings, and children) of someone with a confirmed diagnosis of primary colorectal cancer (C18-C20, C218). Intervention Details Participants will receive six x one hour telephone health coaching sessions over a six week period delivered by study-trained health professionals (‘health coaches’). They will also receive (i) a participant handbook including educational information on lifestyle factors and colorectal cancer screening, (ii) worksheets and (ii) a pedometer. Project Outcomes This project will provide essential information to inform the development of a larger scale randomised controlled trial of the approach. If successful, short term study outcomes will include improved lifestyle factors and health-related quality of life potentially resulting in reduced risk of colorectal cancer, other cancers and other chronic conditions.

COPD is a leading cause of death in Australia and its prevalence is increasing globally. The majority of disease burden and costs in COPD are due to treatment of exacerbations, with hospitalisations being the major component. Almost all comorbidities exist more frequently in COPD patients compared to matched elderly populations. One third of COPD patients admitted to hospital have at least four coded comorbidities, and these add to the length of hospital stay. In selected populations of COPD patients, training in the use of COPD action plans reduces COPD exacerbation severity, emergency department visits, hospitalisations and health costs and improves health status. However, overlap in symptoms of COPD and comorbidities complicate the use of COPD action plans in the large group of patients with comorbidities. For example, in a COPD patient with comorbid cardiovascular disease, worsening of his dyspnoea can relate to either disease. Use of only a COPD action plan could lead to incorrect actions and/or delay of proper treatment. We have developed self-treatment training with ongoing nurse support for complex COPD patients. Feedback to patients from nurses is vital to optimize use of action plans. We will enrol 300 COPD patients (150 in each of Australia and the Netherlands) with at least one of the following comorbidity: ischaemic heart disease, heart failure, diabetes, or anxiety/depression. All patients will complete daily symptom diaries for 12 months. Control patients will receive usual care and training in diary completion. Intervention patients will be trained in the use of individualized action plans. We hypothesize that this novel self-treatment strategy will reduce exacerbation severity, hospitalisation stay and costs, and improve quality of life.